DIORSKIN FOREVER PERFECT MAKEUP EVERLASTING WEAR PORE-REFINING EFFECT WITH SUNSCREEN BROAD SPECTRUM SPF 35 TINTS 014- octinoxate, titanium dioxide emulsion

DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 014 by

Drug Labeling and Warnings

DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 014 by is a Otc medication manufactured, distributed, or labeled by Parfums Christian Dior. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate  3.00%

Titanium Dioxide  1.75%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product,

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending​​ time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months of age: ask a doctor.

Other information

• Protect this product in this container from excessive heat and direct sun.

Inactive ingredients

AQUA (WATER), METHYL TRIMETHICONE, ISODODECANE, ALCOHOL, DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/DIMETHICONE COPOLYMER, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, SILICA, METHYL METHACRYLATE CROSSPOLYMER, BUTYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MICA, ALUMINUM HYDROXIDE, SODIUM MYRISTOYL GLUTAMATE, PHENOXYETHANOL, GLYCERYL UNDECYL DIMETHICONE, PROPYLENE CARBONATE, VP/VA COPOLYMER, STEARIC ACID, PARFUM (FRAGRANCE), TETRASODIUM EDTA, ALGIN, LINALOOL, ROSA MULTIFLORA FRUIT EXTRACT, LIMONENE, BUTYLPHENYL METHYLPROPIONAL, ACACIA SENEGAL GUM, CITRONELLOL, XANTHAN GUM, BHT, SERINE, SODIUM STEARATE, ATELOCOLLAGEN, ZINC GLUCONATE, SODIUM HYALURONATE, SODIUM CHLORIDE, TOCOPHEROL.[MAY CONTAIN: CI 77163 (BISMUTH OXYXHLORIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

Package Labeling:

INGREDIENTS AND APPEARANCE

DIORSKIN FOREVER PERFECT MAKEUP EVERLASTING WEAR PORE-REFINING EFFECT WITH SUNSCREEN BROAD SPECTRUM SPF 35 TINTS 014 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61957-2600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ACACIA (UNII: 5C5403N26O)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SERINE (UNII: 452VLY9402)
SODIUM STEARATE (UNII: QU7E2XA9TG)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61957-2600-1	1 in 1 CARTON	10/14/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/14/2016

Labeler - Parfums Christian Dior (275252245)